The evidence is that IMET can take a marginal to good medicine and improve its effectiveness dramatically. That in itself (in combinations or as part of a cancer-moonshot-cocktail) makes IMET a "transformative" medicine that has almost unlimited potential. The researchers will be busy for many years.
Full cures for ET, remissions in MF, MDS trials looking good, AML studies progressing (with combinations), ODD status in the USA and EU, patient's needs filled by only IMET (many but not all), good safety profile. There are overwhelming reasons for immediate approvals all over the world.
A few words of praise from JNJ or the FDA or another similar agency outside of the USA (could happen next week) would cause Geron's PPS to advance rapidly. It's all about the time factor, and immediate patients' needs. Two years would mean that IMET is very marginal, and has essentially failed. I don't see that outcome in any way. JNJ would have given up by now, but they are expanding the size and scope of the trials.
We are talking about the IMET potential as the telomere length and telomerase puzzle gets solved as one of the vital parts in understanding, treating, curing and preventing many cancers (IMET alone and in combinations with other medicines). Janssen (JNJ) is presenting, and that is very important. We will see if the general market understands the significance.
Thank goodness. JNJ (Janssen subsidiary) is presenting posters #2731 & #2732. There will be other telomere/telomerase presentations. Geron led into the AACR last week (Needham). This is the start of Janssen's " IMET-break silence".
Chapters: 1. ET; 2. MF; 3 AML, 4. Combinations; 5 Cancer Stem Cells; 6 Cancer Vaccines; 7. Cancer Remissions; 8. Cancer Cures; Cancer Prevention (Best Seller)
Imetelstat specific diagnostic kits would be very useful. IMET brings remissions to many (tantamount to a cure), improvements for most, but has no effect for others. A proper kit could help sort out this genetic dilemma, and provide information about combinations.
The IMET-game is JNJ's to win or lose. The worldwide trials are gaining momentum (MF, MDS) with AML pending, and JNJ breaking their silence. Secrets can no longer be kept.
In addition, I believe there is an obligation (moral and legal) that the FDA fill unmet medical needs, especially when lives can be saved. IMET seems to be front and center in its ability to improve cancer patients' treatment (symptoms and disease modifications) and save lives.
The clinical trials will continue for blood cancers (and beyond) indefinably as the results are "are fully assessed and documented" for ET, MF, MDS and soon AML. This is all good news as JNJ appears to have full confidence in IMET as a cornerstone (telomere lengths and telomerase enzymes) in treating, curing (remissions, chronic cancers, full cures), and preventing many cancers (cancer vaccines, cancer stem cells, etc.) alone and in combinations.
There is so much to be learned about the science (building on the Nobel Prize, combination drugs, genetics, etc.). JNJ works closely with the FDA, so additional approvals (beyond ODD) for IMET could and should come very soon. The patient's needs come 1st, and IMET is proven unique, safe and effective. There is nothing to hold it back. Everyone will be listening (AACR, JNJ, others) for updates about the JNJ blood cancer trials.
This is exciting since telomeres and telomerase are important in all cancers. IMET's greatest potential is in combinations with other medicines. Where did you find this reference?
JNJ is in command, but Mayo Clinic and Geron are very much part of the team. Geron developed IMET, then found Mayo Clinic to trial IMET (tantamount to a cure), and together they found JNJ to bring IMET to the world as part of the cancer-moonshot to treat, cure and prevent all cancers.
JNJ has accumulated all of the data: (1) All old Mayo Clinic MF trials; (2) New worldwide trials (MF & MDs). They know the answers and are beginning to break their IMET silence.
It seems to me if JNJ had any doubts about IMET as "a blockbuster, or platform therapy or top 5 prospect" they would not keep expanding the depth and scope of the blood cancer trials (MF, MDS, AML). JNJ is very conservative and very reliable. The Mayo Clinic's earlier MF trials were very convincing.
JNJ up to now has been reluctant to let Scarlett loose to praise IMET to the sky (as some say that he should do) with terms like: miracle medicine, the cure for cancer, vaccine to prevent all cancers, etc.
There are only so many "praises" that one can give a medicine legally, and JNJ is well aware of those limitations. Yet IMET (alone and in combinations) is slowly proving to be all of these things, with consistent good news and little, if any, bad news. The worst that you can say about IMET is that, so far, it doesn't work for all blood cancer patients with different levels of improvements (none to full remissions). JNJ is opening up (starting with the AACR). News about the worldwide trials cannot be far off.
Needham featured a 79 year MF patient that had amazing success with IMET. Scarlett was limited in what he could say (by JNJ), so he took a strong example of an IMET success story. The JNJ filter is working, with more good news to come. IMET by itself is very powerful (remissions and cures never seen before--ET, MF, MDS). The JNJ/Janssen trials continue to expand.
IMET in combinations is more powerful, with another blood cancer (AML) being the next target (Needham). The "holy grail" is a cancer vaccine to prevent cancer and get at cancer stem cells, with IMET as a vital component.. That is in the works.
I agree. No "bad" news means that the JNJ/IMET trials are going as planned with disease modifications and with improved and limited infusions.
IMET (Geron's PPS) has been lost in the confusion, but still seems to have JNJ's full support.
JNJ has supported Imetelstat (IMET) to the hilt. Still Geron's PPS is about $3, while Piper Jaffray is calling for $10. It is hard to know why there is such a mismatch. Part of that has been blamed on hedge funds, part of that has been blamed on Scarlett, and part of that has been blamed on IMET (some say doesn't really work very well).
My premise has always been is that JNJ is in control, what they say can be relied upon, and IMET keeps meeting the "challenges". Beyond blood cancers, we are now talking about cancer vaccines, solid tumors, and cancer stem cells as IMET targets (alone and in combinations).
I am surprised there have not been more comments. As we thought, Scarlett (as a JNJ spokesman) would make interesting, forward looking, and "transformative" comments about IMET, but the investing community, for the most part, does not listen to him. The "real" JNJ, the FDA and perhaps similar agencies outside the USA, can move the stock to Piper Jaffray's $10 target. The good news about IMET is out, but JNJ has not spoken "loud and clear" to support Geron's (JNJ Jr.) PPS.
As Imbark and Imerge (MF & MDS) proceed, there has been no mention of new remissions. That was the core of the Mayo Clinic (Dr. Tefferi) trials. The trials are moving on with AML being added. There were no questions about remissions. There do not appear to be any new safety related problems, and all trials appear to be on schedule, and expanding. JNJ and the FDA have not spoken. Patient's needs are the #1 consideration, and IMET works for some, but not for all (alone). Combinations are being considered for improved results.